ID
36125
Beschreibung
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Notification Form form. Complete as may sections ofthis form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail of fax (fax preferred) within two weeks ofleaming ofthepregnancy.After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject's Case Report From.
Stichworte
Versionen (2)
- 15.04.19 15.04.19 -
- 16.04.19 16.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. April 2019
DOI
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Pregnancy Notification Form
- StudyEvent: ODM
Beschreibung
Reporter Information
Alias
- UMLS CUI-1
- C3840395
Beschreibung
Reporter name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigators Title
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beschreibung
Investigators Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschreibung
Telephone No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beschreibung
Fax No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beschreibung
City, State/Province
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [2,1]
- C1547742
- UMLS CUI [2,2]
- C0008961
Beschreibung
Postal Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0008961
Beschreibung
Country
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beschreibung
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0026591
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beschreibung
(i.e. Include alcohol, tobacco and substance abuse, complications of past pregnancy, labor/delivery, fetus/baby, illnesses during this pregnancy, assisted conception specify, other disorders including familial birth defects/genetic/chromosomal disorders, method of diagnosis consanguinity etc.)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0026591
- UMLS CUI [2,2]
- C0241889
Beschreibung
Number of previous Pregnancies
Datentyp
integer
Alias
- UMLS CUI [1]
- C3814420
Beschreibung
Number of previous Pregnancies
Datentyp
integer
Alias
- UMLS CUI [1]
- C0151526
Beschreibung
Birth Termination
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1283212
- UMLS CUI [1,2]
- C0005615
Beschreibung
Father's relevant medical/family history
Alias
- UMLS CUI-1
- C0015671
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beschreibung
Information provided
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
Beschreibung
Information reported, other
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
- UMLS CUI [1,3]
- C0205394
Beschreibung
(i.e, Include chronic illnesses: specify, familial birth defects/genetic/chromosomal disorders,habitual exposure: specify, alcohol/tobacco, drug exposure: specify, substance abuse and medication use)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0015671
- UMLS CUI [2,2]
- C0241889
Beschreibung
Father Unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beschreibung
Number of children
Datentyp
integer
Alias
- UMLS CUI [1]
- C2229974
Beschreibung
Fathers Age
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Beschreibung
Fathers Race
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Beschreibung
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
Alias
- UMLS CUI-1
- C1546482
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2347852
Beschreibung
Drug/Vaccine/OTC Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0027365
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C0027365
- UMLS CUI [3,1]
- C0013231
- UMLS CUI [3,2]
- C0027365
Beschreibung
Dosing Regimen and Frequency of Dosing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [2]
- C2982514
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Check Box if Continuing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beschreibung
Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C3146298
Beschreibung
Current pregnancy information/status
Alias
- UMLS CUI-1
- C0552579
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0425932
Beschreibung
Last Period Unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2825543
Beschreibung
Pregnancy status
Datentyp
integer
Alias
- UMLS CUI [1]
- C0552579
Beschreibung
Delivery Method
Datentyp
text
Alias
- UMLS CUI [1]
- C0565867
Beschreibung
If one of these boxes is checked, please note details in ,,Additional details" below
Datentyp
integer
Alias
- UMLS CUI [1]
- C0156543
Beschreibung
Other early termination
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0156543
- UMLS CUI [1,2]
- C0205394
Beschreibung
If "Birth defect" or "Other disorder" is checked please note deatils in "Additional details" below
Datentyp
integer
Alias
- UMLS CUI [1]
- C3503749
- UMLS CUI [2]
- C4042838
Beschreibung
Multiple births
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2015861
- UMLS CUI [1,2]
- C2229974
Beschreibung
(send separate form for each child) Please submit additional information on a separate sheet.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005607
Beschreibung
Discharge summary notes
Datentyp
text
Alias
- UMLS CUI [1]
- C0242482
Beschreibung
Additional details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1546922
- UMLS CUI [1,2]
- C0747843
- UMLS CUI [2,1]
- C1546922
- UMLS CUI [2,2]
- C0022864
- UMLS CUI [3,1]
- C1546922
- UMLS CUI [3,2]
- C0005615
- UMLS CUI [4,1]
- C1546922
- UMLS CUI [4,2]
- C0015965
- UMLS CUI [5,1]
- C1546922
- UMLS CUI [5,2]
- C0021270
Beschreibung
Infant information
Alias
- UMLS CUI-1
- C0511470
Beschreibung
Gestational weeks at birth/miscarriage/termination
Datentyp
integer
Maßeinheiten
- weeks
Alias
- UMLS CUI [1,1]
- C0439671
- UMLS CUI [1,2]
- C0439230
- UMLS CUI [1,3]
- C0005615
- UMLS CUI [2,1]
- C0439671
- UMLS CUI [2,2]
- C0439230
- UMLS CUI [2,3]
- C0000786
- UMLS CUI [3,1]
- C0439671
- UMLS CUI [3,2]
- C0439230
- UMLS CUI [3,3]
- C0156543
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005615
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0000786
- UMLS CUI [3,1]
- C0011008
- UMLS CUI [3,2]
- C0156543
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2361123
Beschreibung
Length of infant
Datentyp
float
Alias
- UMLS CUI [1,1]
- C1444754
- UMLS CUI [1,2]
- C0021270
Beschreibung
Unit Length
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C1444754
Beschreibung
Weight of infant
Datentyp
float
Alias
- UMLS CUI [1]
- C0745274
Beschreibung
Unit Weight
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C0043100
Beschreibung
0-10
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003533
Beschreibung
Apgar Score unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0003533
- UMLS CUI [1,2]
- C0439673
Beschreibung
Relevant Laboratory Test and Procedures
Alias
- UMLS CUI-1
- C0022885
Beschreibung
(e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation) In case of an abnormal evolution or outcome, please send a copy of all relevant laboratory tests and procedures and complete the AE or SAE form as appropriate.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0085415
Beschreibung
Drug/Vaccine related problems
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0033213
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C2347852
- UMLS CUI [2,3]
- C0033213
Beschreibung
Reporter's signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
(If not the same as reporter)
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
Pregnancy Notification Form
- StudyEvent: ODM
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C1547742 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0005615 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C1709908 (UMLS CUI [1,2])
C1709908 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C0015671 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0439673 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2347852 (UMLS CUI-4)
C0027365 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0027365 (UMLS CUI [2,2])
C0013231 (UMLS CUI [3,1])
C0027365 (UMLS CUI [3,2])
C0678766 (UMLS CUI [1,2])
C2982514 (UMLS CUI [2])
C0439673 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C4042838 (UMLS CUI [2])
C2229974 (UMLS CUI [1,2])
C0747843 (UMLS CUI [1,2])
C1546922 (UMLS CUI [2,1])
C0022864 (UMLS CUI [2,2])
C1546922 (UMLS CUI [3,1])
C0005615 (UMLS CUI [3,2])
C1546922 (UMLS CUI [4,1])
C0015965 (UMLS CUI [4,2])
C1546922 (UMLS CUI [5,1])
C0021270 (UMLS CUI [5,2])
C0439230 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
C0439671 (UMLS CUI [2,1])
C0439230 (UMLS CUI [2,2])
C0000786 (UMLS CUI [2,3])
C0439671 (UMLS CUI [3,1])
C0439230 (UMLS CUI [3,2])
C0156543 (UMLS CUI [3,3])
C0005615 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0000786 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3,1])
C0156543 (UMLS CUI [3,2])
C0021270 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0085415 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])